FDA Adverse Event
Malfunction
Summary report: N
TRUETRACK
MDR report key: 2081842
·
Received April 4, 2011
Report
- Report Number
- 1052693-2011-00017
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 22, 2011
- Report Date
- April 5, 2011
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PUBLIX COMMUNICATED THIS COMPLAINT. CUSTOMER FELT HIS METER RESULTS WERE HIGH AND HE COULD NOT CONTROL HIS BLOOD SUGAR. CUSTOMER STATES HE WENT TO THE EMERGENCY ROOM AND THE DIFFERENCE BETWEEN READING WAS 200 PTS. NO OTHER DETAILS PROVIDED TO UNDERSTAND ANY TIME FRAMES OR WHAT INSTRUMENTS WERE USED FOR COMPARISON OF GLUCOSE LEVELS. NO INJURY REPORTED. ACCORDING TO PUBLIX, THE METER WAS DISCARDED AND THERE ARE NO TEST STRIPS LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUETRACK | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RL3382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |